SARCLISA

This brand name is authorized in Austria, Brazil, Canada, Estonia, Finland, France, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, United States

Active ingredients

The drug SARCLISA contains one active pharmaceutical ingredient (API):

1 Isatuximab
UNII R30772KCU0 - ISATUXIMAB

Isatuximab is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab induces apoptosis of tumor cells and activation of immune effector mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement dependent cytotoxicity (CDC). It is used in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma (MM).

Read about Isatuximab

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
SARCLISA Concentrate for solution for infusion European Medicines Agency (EU) MPI, EU: SmPC
SARCLISA Concentrate solution for injection FDA, National Drug Code (US) MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01FC02 Isatuximab L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FC CD38 (Clusters of Differentiation 38) inhibitors
Discover more medicines within L01FC02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: BR Câmara de Regulação do Mercado de Medicamentos Identifier(s): 576721070094602, 576721070094702
Country: CA Health Products and Food Branch Identifier(s): 02498235, 02498243
Country: EE Ravimiamet Identifier(s): 1821024, 1821035, 1821046
Country: FI Lääkealan turvallisuus- ja kehittämiskeskus Identifier(s): 133049, 458904
Country: FR Base de données publique des médicaments Identifier(s): 66510210
Country: GB Medicines & Healthcare Products Regulatory Agency Identifier(s): 387145, 387148
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291454A1021, 4291454A2028
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1090347, 1090348, 1090349
Country: NL Z-Index G-Standaard, PRK Identifier(s): 204293, 204307
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100434592
Country: RO Agenția Națională a Medicamentului și a Dispozitivelor Medicale Identifier(s): W69367001, W69367002, W69367003
Country: TR İlaç ve Tıbbi Cihaz Kurumu Identifier(s): 8699809779259, 8699809779266
Country: US FDA, National Drug Code Identifier(s): 0024-0654, 0024-0656

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